Identity
- Device Name
- Latex Probe Cover EUDAMED
- Model / Reference
- Probe Cover EUDAMEDELT 085-ELT 086 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09554100448671 EUDAMED
- Basic UDI-DI
- 955410035270PROBECOVERWT EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Latex Probe Cover by Eurolatex Sdn. Bhd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955410035270PROBECOVERWT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eurolatex Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000003748
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED dd15b202-0c9a-4675-8618-9d3843d38787 61 fields · synced Jun 18, 2026